{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,5]],"date-time":"2026-01-05T22:15:21Z","timestamp":1767651321253,"version":"3.44.0"},"reference-count":32,"publisher":"BMJ","issue":"8","funder":[{"DOI":"10.13039\/100006093","name":"Patient-Centered Outcomes Research Institute","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006093","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006108","name":"National Center for Advancing Translational Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006108","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Med Ethics"],"accepted":{"date-parts":[[2018,3,21]]},"published-print":{"date-parts":[[2018,8]]},"abstract":"<jats:p>Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the feasibility of upholding ethical standards without imposing undue burden on clinical workflows, staff members or patients who may participate in the research by virtue of their presence in a cluster randomised facility. The COMPASS study included 40 randomised sites and compared the effectiveness of a postacute stroke intervention with standard care. Each site provided either the comprehensive postacute stroke intervention or standard care according to the randomisation assignment. Working together, the study team, institutional review board and members of the community designed an ethically appropriate and operationally reasonable consent process which was carried out successfully at all randomised sites. This achievement is noteworthy because it demonstrates how to effectively conduct appropriate informed consent in cluster randomised trials, and because it provides a model that can easily be adapted for other pragmatic studies. With this innovative approach to informed consent, patients have access to the information they need about research occurring where they are seeking care, and medical researchers can conduct their studies without ethical concerns or unreasonable logistical impediments.<\/jats:p>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02588664\" ext-link-type=\"uri\">NCT02588664<\/jats:ext-link>, recruiting. This article covers the development of consent process that is currentlty being employed in the study.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/medethics-2017-104478","type":"journal-article","created":{"date-parts":[[2018,7,26]],"date-time":"2018-07-26T04:15:28Z","timestamp":1532578528000},"page":"560-566","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":16,"title":["Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial"],"prefix":"10.1136","volume":"44","author":[{"given":"Joseph E","family":"Andrews","sequence":"first","affiliation":[{"name":"Institutional Review Board, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J Brian","family":"Moore","sequence":"additional","affiliation":[{"name":"Institutional Review Board, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard B","family":"Weinberg","sequence":"additional","affiliation":[{"name":"Institutional Review Board, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mysha","family":"Sissine","sequence":"additional","affiliation":[{"name":"Department of Neurology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sabina","family":"Gesell","sequence":"additional","affiliation":[{"name":"Public Health Sciences Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacquie","family":"Halladay","sequence":"additional","affiliation":[{"name":"Department of Family Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wayne","family":"Rosamond","sequence":"additional","affiliation":[{"name":"Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheryl","family":"Bushnell","sequence":"additional","affiliation":[{"name":"Department of Neurology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sara","family":"Jones","sequence":"additional","affiliation":[{"name":"Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paula","family":"Means","sequence":"additional","affiliation":[{"name":"Institutional Review Board, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nancy M P","family":"King","sequence":"additional","affiliation":[{"name":"Center for Bioethics, Health, and Society; Public Health Sciences Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diana","family":"Omoyeni","sequence":"additional","affiliation":[{"name":"Institutional Review Board, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pamela W","family":"Duncan","sequence":"additional","affiliation":[{"name":"Department of Neurology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2018,5,2]]},"reference":[{"key":"2025092414414668000_44.8.560.1","first-page":"23192","article-title":"Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research","volume":"44","year":"1979","journal-title":"Fed Regist"},{"key":"2025092414414668000_44.8.560.2","doi-asserted-by":"publisher","DOI":"10.1111\/jlme.12256"},{"key":"2025092414414668000_44.8.560.3","unstructured":"Nuremberg October 1946 \u2013 April 1949. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Permissible Medical Experiments. 2. Washington: U.S. Government Printing Office:181\u20132."},{"key":"2025092414414668000_44.8.560.4","doi-asserted-by":"publisher","DOI":"10.1001\/jama.290.12.1624"},{"key":"2025092414414668000_44.8.560.5","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMhle1312508"},{"key":"2025092414414668000_44.8.560.6","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMhle1313674"},{"key":"2025092414414668000_44.8.560.7","doi-asserted-by":"publisher","DOI":"10.7326\/M15-0817"},{"key":"2025092414414668000_44.8.560.8","unstructured":"Lantos K , Slutsman J , Whicher D . Management of Human Subjects Protections in Conducting Pragmatic Clinical Studies. National Harbor, MD: Session presented at the Patient-Centered Outcomes Research Institute (PCORI) Annual Meeting, 2016."},{"key":"2025092414414668000_44.8.560.9","doi-asserted-by":"crossref","first-page":"193","DOI":"10.1007\/s11017-016-9364-x","article-title":"When clinical care is like research: the need for review and consent","volume":"37","author":"Wendler","year":"2016","journal-title":"Theor Med Bioeth"},{"key":"2025092414414668000_44.8.560.10","doi-asserted-by":"crossref","unstructured":"Faden RR , Kass NE , Goodman SN , et al . An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep 2013;(Suppl 1):S16\u2013S27.doi:10.1002\/hast.134","DOI":"10.1002\/hast.134"},{"key":"2025092414414668000_44.8.560.11","doi-asserted-by":"publisher","DOI":"10.2105\/AJPH.2011.300389"},{"key":"2025092414414668000_44.8.560.12","doi-asserted-by":"publisher","DOI":"10.1177\/1740774515571140"},{"key":"2025092414414668000_44.8.560.13","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsb025342"},{"key":"2025092414414668000_44.8.560.14","doi-asserted-by":"crossref","first-page":"125","DOI":"10.1080\/23294515.2016.1155674","article-title":"Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System","volume":"7","author":"Lee","year":"2016","journal-title":"AJOB Empir Bioeth"},{"key":"2025092414414668000_44.8.560.15","unstructured":"IOM (Institute of Medicine). Best care at lower cost: The path to continuously learning health care in America. Washington, DC: The National Academies Press, 2013. http:\/\/nap.edu\/13444"},{"key":"2025092414414668000_44.8.560.16","doi-asserted-by":"crossref","first-page":"121","DOI":"10.1017\/cts.2016.26","article-title":"Methods guiding stakeholder engagement in planning a pragmatic study on changing stroke systems of care","volume":"1","author":"Gesell","year":"2017","journal-title":"J Clin Transl Sci"},{"key":"2025092414414668000_44.8.560.17","unstructured":"COMPASS. COMprehensive Post-Acute Stroke Services (REDACTED) Study. https:\/\/www.nc[Redacted]-study.org"},{"key":"2025092414414668000_44.8.560.18","unstructured":"U.S. National Library of Medicine. Clinicaltrials.gov registration. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02588664"},{"key":"2025092414414668000_44.8.560.19","unstructured":"Public Welfare Security and Privacy. 45 C.F.R. \u00a7 164 (2000)."},{"key":"2025092414414668000_44.8.560.20","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199903113401013"},{"key":"2025092414414668000_44.8.560.21","unstructured":"Wake Forest School of Medicine. An open letter to the office for human research protections via regulations.gov. 2016 https:\/\/www.regulations.gov\/document?D=HHS-OPHS-2015-0008-1320"},{"key":"2025092414414668000_44.8.560.22","doi-asserted-by":"publisher","DOI":"10.7326\/M15-0166"},{"key":"2025092414414668000_44.8.560.23","doi-asserted-by":"crossref","first-page":"116","DOI":"10.1080\/23294515.2016.1161672","article-title":"The patient\u2019s perspective on the need for informed consent for minimal risk studies: development of a survey-based measure","volume":"7","author":"Kaplan","year":"2016","journal-title":"AJOB Empir Bioeth"},{"key":"2025092414414668000_44.8.560.24","doi-asserted-by":"publisher","DOI":"10.1001\/jama.283.20.2701"},{"key":"2025092414414668000_44.8.560.25","doi-asserted-by":"crossref","first-page":"613","DOI":"10.1056\/NEJMp1700736","article-title":"The common rule, updated","volume":"376","author":"Menikoff","year":"2017","journal-title":"N Engl J Med"},{"key":"2025092414414668000_44.8.560.26","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1007\/s11019-016-9721-6","article-title":"Trust me, I\u2019m a researcher!: the role of trust in biomedical research","volume":"20","author":"Kerasidou","year":"2017","journal-title":"Med Health Care Philos"},{"key":"2025092414414668000_44.8.560.27","doi-asserted-by":"publisher","DOI":"10.1177\/1740774515597688"},{"key":"2025092414414668000_44.8.560.28","unstructured":"Institute of Medicine. Best care at lower cost: The path to continuously learning health care in America. Washington, DC: The National Academies Press, 2013. http:\/\/nap.edu\/13444. (accessed 12 May 2017)."},{"key":"2025092414414668000_44.8.560.29","unstructured":"Public welfare security and privacy. 45 C.F.R. \u00a7 46 (2009)."},{"key":"2025092414414668000_44.8.560.30","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1001346"},{"key":"2025092414414668000_44.8.560.31","first-page":"40325","article-title":"Final NIH policy on the use of a single institutional review board for multi-site research","volume":"81","year":"2016","journal-title":"Fed Regist"},{"key":"2025092414414668000_44.8.560.32","first-page":"53933","article-title":"Federal policy for the protection of human subjects; proposed rules","volume":"80","year":"2015","journal-title":"Fed Regist"}],"container-title":["Journal of Medical Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/medethics-2017-104478","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,24]],"date-time":"2025-09-24T21:43:07Z","timestamp":1758750187000},"score":1,"resource":{"primary":{"URL":"https:\/\/jme.bmj.com\/lookup\/doi\/10.1136\/medethics-2017-104478"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,5,2]]},"references-count":32,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2018,7,26]]},"published-print":{"date-parts":[[2018,8]]}},"alternative-id":["10.1136\/medethics-2017-104478"],"URL":"https:\/\/doi.org\/10.1136\/medethics-2017-104478","relation":{},"ISSN":["0306-6800","1473-4257"],"issn-type":[{"type":"print","value":"0306-6800"},{"type":"electronic","value":"1473-4257"}],"subject":[],"published":{"date-parts":[[2018,5,2]]}}}